Senior Director Director, Non-Clinical Safety Project Specialist

Position Summary

This key Non-Clinical Safety Leadership role will actas a Project Team Member consultant mentor and reviewer across discovery and development projects. Accountable for the quality of scientific thinking and outputs that characterise non-clinical safety drug disposition and on-/off-target engagement for potential therapies integrating data and knowledge into clear project narratives optimized development plans regulatory documents and decision-making. Through direct project delivery cross-functional influence and support of the wider PTM community enable the safe and efficient progression of medicines through clinical development approval and where required post-market support.

Key Responsibilities

• Represent non-clinical safety as a Project Team Member providing strategic input to integrated project plans across discovery development and where required post-market support.
• Lead or contribute to the design coordination and delivery of optimized non-clinical safety and translational project plans that support key decision points.
• Integrate scientific data and knowledge into clear evidence-based narratives for internal governance project strategy regulatory documents submissions and responses to regulatory questions.
• Provide expert consultancy on target liabilities candidate selection safety screening on-/off-target engagement due diligence opportunities and marketed product issues as required.
• Influence cross-functional stakeholders governance bodies and regulators through high-quality scientific judgement communication negotiation and decision support.
• Support capability and quality across the PTM community through coaching mentoring training peer review and approval of key internal and regulatory documents.
• Contribute to regulatory strategy and lead or support global regulatory submissions (e.g. CTA IND MAA NDA) ensuring aligned non-clinical safety positions and high-quality documentation.
• Lead or provide significant input to major scientific or technical initiatives including organisational changes affecting non-clinical safety and DMPK project delivery.
• Ensure clear line of sight and leadership on project safety issues and progression challenges leveraging relevant SMEs as required.
• Promote flexible courageous scientific thinking by providing multiple options and riskbenefit perspectives to project teams EDLs/MDLs and governance bodies.

Basic Qualifications:

• Advanced degree (PhD DVM MD or equivalent) in a relevant scientific discipline
• Significant experience in non-clinical safety within pharmaceutical or biotech drug development
• Experience supporting regulatory submissions (e.g. IND CTA NDA BLA)
• Demonstrated ability to lead or contribute to non-clinical safety strategies across discovery and/or development
• Strong cross-functional collaboration skills with disciplines such as Pharmacology DMPK and Clinical Development
• Proven ability to interpret and integrate complex data into regulatory and strategic narratives

Preferred Qualifications:

• Experience with complex NCE and biologic modalities
• Recognised expertise in a specialist area of toxicology (e.g. genetic reproductive inhalation)
• Professional certification (e.g. DABT ERT)
• Established external scientific reputation (publications advisory roles regulatory interactions)
• Experience mentoring and developing other scientists or PTMs
• Track record of leading major scientific or organisational initiatives
• Experience influencing senior governance bodies and regulatory agencies

If you are based in Cambridge MA; Waltham MA; Rockville MD; or San Francisco CA the annual base salary for new hires in this position ranges $224400 to $374000. The US salary ranges take into account a number of factors including work location within the US market the candidates skills experience education level and the market rate for the addition this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country the relevant compensation will be discussed during the recruitment process.

Why GSK

Uniting science technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade as a successful growing company where people can thrive.

We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory immunology and inflammation; oncology; HIV; and infectious diseases to impact health at scale.

People and patients around the world count on the medicines and vaccines we make so were committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race color religion sex (including pregnancy gender identity and sexual orientation) parental status national origin age disability genetic information (including family medical history) military service or any basis prohibited under federal state or local law.

We believe in an agile working culture for all our roles. If flexibility is important to you we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at where you can also request a call.

Please note should your enquiry not relate to adjustments we will not be able to support you through these channels. However we have created a Recruitment FAQ guide. Click the Link where you will find answers to multiple questions we receive

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license GSK may be required to capture and report expenses GSK incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSKs compliance to all federal and state US Transparency requirements. For more information please visit the Centers for Medicare and Medicaid Services (CMS) website at Experience:

Exec

Employment Type : Full-Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 224400 - 374000